October 25, 2002

Vanderbilt experts step up to smallpox

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Dr. William Schaffner

Vanderbilt experts step up to smallpox

Dr. Kathryn Edwards

Dr. Kathryn Edwards

Two Vanderbilt physicians are working to help devise the national policy on smallpox vaccination and management of potential complications if and when mass vaccination is begun.

Dr. William Schaffner, chair of Preventive Medicine and a member of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, participated Oct. 17-18 as a member of the smallpox vaccine working group in widely publicized meetings that produced smallpox vaccination recommendations.

Dr. Kathryn Edwards, professor of Pediatrics, principal investigator of the NIH-funded smallpox vaccine trials now underway at Vanderbilt, and principal investigator of the CDC-sponsored Center for Immunization Safety Assessment (CISA), will be part of a national monitoring and consultation network. She will join other CISA colleagues from Columbia-New York Presbyterian Hospital in Manhattan, Boston University, Johns Hopkins, the University of Maryland, the Northern California Kaiser Permanente hospital and Stanford University as consultants to provide physicians and other health care professionals advice on questions about the smallpox vaccine or the disease itself.

Last week’s meeting dealt with a series of nuts-and-bolts issues about how smallpox vaccination programs would be carried out, Schaffner said. “There are numerous nitty-gritty, but important details,” he said. The first was the decision to recommend vaccinating hospital employees who would care for people in the event of a smallpox outbreak — some half million emergency room nurses, physicians, X-ray technicians and similar staff in medical intensive care units.

Vaccine clinical trials such as Edwards’ study provided for practical information on the rates and severity of reactions seen when smallpox vaccine is given since the vaccine hasn’t been given in the United States since 1972. Among them: the realization that after vaccination many people require a day or two off from work as they nurse side effects, such as fever and soreness, which suggests vaccinations should be staggered; and how many bandages are enough to prevent transmission (two).

According to the committee’s report, Schaffner said, the vaccine would be given first only to volunteers in ER and ICU settings. People should not receive the vaccine if they are pregnant, have deficient immune systems or have ever had eczema or atopic dermatitis because of the possibility of a severe side effect called eczema vaccinatum. Anyone living in close contact with a person who has any of these contraindications should not receive the vaccine.

The committee decided that the plan would unroll with a day of instruction about the vaccine and the virus, to give them time to determine if they are suitable. Privacy issues were also discussed, and it was decided that pregnancy tests would be offered, but not required, and volunteers could avail themselves of HIV tests, but those would also not be mandatory.

Unlike previous meetings in which discussion can drag on, Schaffner said, the recent coming together of ideas “went as smooth as silk. Each of the questions had been thoroughly researched in working groups before it was brought to the main committee. … This will be a vaccination program that will be monitored for safety with enormous care.”

Schaffner has continually played a key role in discussions of biological agents generally, and smallpox specifically, because he saw people with smallpox as a member of the U.S. Public Health Service.

“It was January, 1967. I was in the major infectious disease hospital in New Delhi and we went to the smallpox ward,” he said. “There were 40 to 50 patients with smallpox, even a nursing infant who had one big pock, right on the top of his head. But the mother and child were doing well and were on the road to recovery.”

Edwards has participated in many of the major vaccine clinical studies in the past 25 years, including those for influenza, pertussis and pneumoccal infections.